US-based medical device company Apreo Health has initiated its BREATHE-3 clinical trial by treating the first patient with its BREATHE Airway Scaffold.
The BREATHE Airway Scaffold is designed to alleviate lung hyperinflation in severe emphysema patients who struggle with breathing despite optimal medical care.
The BREATHE-3 trial will enrol up to 250 participants across 25 sites in Europe and the US, with a three-year follow-up period.
The study will assess the safety and efficacy of the BREATHE Airway Scaffold, focusing on lung function, quality of life, and exercise capacity improvements.
The trial builds on promising results from earlier feasibility studies, BREATHE 1 and 2, which showed a 92.4% technical success rate without pneumothorax complications.
BREATHE-3 study principal investigator Gerard Criner said: “For years, the field has been searching for a safer, more broadly applicable way to address emphysema-related hyperinflation.
“The BREATHE Airway Scaffold offers a novel approach that allows treatment of the whole lung while eliminating the risk of pneumothorax and procedural complexities that have limited broader adoption of current interventions.
“This trial is a key step in evaluating a therapy that could meaningfully expand interventional treatment access for patients today who have few options.”
The BREATHE Airway Scaffold is a bronchoscopically delivered, self-expanding implant designed to release air from hyperinflated lungs.
The device is engineered to resist foreign body reactions and ensure durable effects.
In May 2024, Apreo Health received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for the BREATHE Airway Scaffold.
Apreo Health, formed at the medtech incubator, The Foundry, is focused on interventional pulmonology, offering a tissue-sparing approach to treating severe emphysema.
The company is supported by investors including Bain Capital Life Sciences, F-Prime, Intuitive Ventures, Lightstone Ventures, Norwest, Santé Ventures, and The Foundry.
Apreo Health CEO Karun Naga said: “Treating not only the first patient in our pivotal BREATHE-3 trial, but also the first patient in the US, marks a defining moment for Apreo and a critical milestone in the path to changing the standard of care for millions of people who’ve been left behind by existing treatment options.
“With this study, we’re advancing a therapy designed to fit the realities of everyday clinical practice, enabling broader use by physicians, and ultimately better outcomes for patients.”
